Externally worn transceiver for use with an implantable medical device

ABSTRACT

An implantable medical device system that includes an implantable medical device, along with a transceiver device that exchanges data with the patient, between the patient and the implantable medical device, and between a remote location and the implantable medical device. A communication device coupled to the transceiver device exchanges data with the transceiver device, the implantable medical device through the receiver device, and between the transceiver device and the remote location to enable bi-directional data transfer between the patient, the implantable medical device, the transceiver device, and the remote location. A converter unit converts transmission of the data from a first telemetry format to a second telemetry format, and a user interface enables information to be exchanged between the transceiver device and the patient, between the implantable medical device and the patient through the transceiver device, and between the patient and the remote location through the transceiver device.

RELATED APPLICATIONS

[0001] This application claims priority and other benefits from U.S.Provisional Patent Application Serial No. 60/243,612, filed Oct. 26,2000, entitled “EXTERNALLY WORN TRANSPONDER/SENSOR FOR USE WITH ANIMPLANTABLE MEDICAL DEVICE”

FIELD OF THE INVENTION

[0002] The present invention generally relates to implantable medicaldevices and communication therewith, and in particular, the presentinvention relates to a transceiver device in proximity to theimplantable medical device and an external sensor that cooperates withthe implantable medical device to produce a desired therapy in one ormore implantable medical devices.

BACKGROUND OF THE INVENTION

[0003] Various medical devices have been developed that acquireinformation from one or more physiologic sensors or transducers. Atypical physiologic sensor transduces a measurable parameter of thehuman body, such as blood pressure, electrical activity (ECG),temperature or oxygen saturation, for example, into correspondingelectrical signals. In many implantable medical device applications, itis often desirable or necessary to acquire physiological data forextended periods of time and on a continuous basis. In addition to thecontinuous acquisition of physiological data, there are manyapplications in which it is often desirable to implement a patient diaryof sorts by enabling the patient to input relevant information atappropriate times so that the combined continuous data acquisition andpatient input provides a record that can be used to better understandother physiologic events or to create signals.

[0004] A problem well known to designers of implantable medical devices,such as pacemakers, for example, concerns the necessity of using lowpower components, including low power memory and processing components,within the implantable medical device. Use of low powered components isconsidered necessary in order to provide for extended periods ofimplantable medical device operation, and to reduce the need torepeatedly replace batteries, which can only be accomplished throughsurgical means. As a consequence, conventional implantable medicaldevices typically employ low voltage, low current memory and processingdevices, which have limited storage capacity and access speed, and oftenlag behind the state-of-the-art memory and processing technology byseveral years. These and other limitations significantly decrease thedata storage, processing power, and access capability of implantablemedical devices, and often precludes the opportunity to integrate highcapacity, low cost, state-of-the-art memory and processing devices inimplantable medical device designs.

[0005] Various implementations of portable or user-wornelectrocardiographic recording/monitoring devices are known in the art,examples of which may be found in the issued patents list in Table 1below. TABLE 1 Pat. No. Inventor(s) Issue Date 6,200,265 Walsh et al.March 13, 2001 5,833,603 Kovacs et al. November 10, 1998 5,721,783Anderson February 24,1998 5,720,770 Nappholz et al. February 24, 19985,759,199 Snell et al. June 2, 1998 5,634,468 Platt et al. June 3, 19975,511,553 Segalowitz April 30, 1996 5,289,824 Mills et al. March 1, 19945,191,891 Righter March 9, 1993 5,113,869 Nappholz et al. May 19, 19924,660,568 Cosman April 28, 1987 4,622,979 Katchis et al. November 18,1986 4,494,950 Fischell January 22, 1985

[0006] Conventional portable or patient-worn electrocardiographic (ECG)monitor/recorders, such as those disclosed in one or more of the patentslisted in Table 1 above, are autonomous systems that enable only limitedinteraction between the patient and the device, and can only be used inaccordance with a single specific telemetry format. Accordingly, what isneeded is a device for communicating with an implantable medical devicethat allows increased patient interaction with the device, seamlesstransmission of data to other devices, including an internet appliance,a cellular network, and so forth, enabling use across multiple telemetryformats and between multiple implantable medical devices to store andmanage information from a broad range of devices.

SUMMARY OF THE INVENTION

[0007] The present invention relates to an implantable medical devicesystem that includes an implantable medical device for implantationwithin a patient that monitors physiologic conditions of the patientand/or delivers a therapy in response to physiologic conditions. Atransceiver device coupled to the implantable medical device along awireless link exchanges data with the patient, between the patient andthe implantable medical device, and between a remote location and theimplantable medical device. A communication device coupled to thetransceiver device along a wireless link exchanges data with thetransceiver device and with the implantable medical device through thetransceiver device, and exchanges data between the transceiver deviceand the remote location. In this way, the implantable medical devicesystem enables bi-directional data transfer between the patient, theimplantable medical device, the transceiver device, the communicationdevice, and the remote location.

[0008] According to a preferred embodiment of the present invention, apatient wearable transceiver device exchanges data with an implantablemedical device for implantation within a patient. The transceiver deviceincludes means for receiving information from the implantable medicaldevice, means for exchanging data between the patient, the implantablemedical device, the communication device, and a remote location, andmeans for processing the data exchanged. The means for receiving, themeans for exchanging, and the means for processing enable bi-directionaldata transfer between the patient, the implantable medical device, thetransceiver device, and the remote location.

[0009] Another aspect of the present invention includes a converter unitthat converts transmission of the data between the implantable medicaldevice, the transceiver device, and the communication device from afirst telemetry format to a second telemetry format.

[0010] In yet another aspect of the present invention, an implantablemedical device system includes an implantable medical device forimplantation within a patient that monitors physiologic conditions ofthe patient, and/or delivers a therapy in response to the physiologicconditions, along with a transceiver device coupled to the implantablemedical device along a wireless link that exchanges data with thepatient, between the patient and the implantable medical device, andbetween a remote location and the implantable medical device. Acommunication device coupled along a wireless link to the transceiverdevice exchanges data with the transceiver device and with theimplantable medical device through the transceiver device, and exchangesdata between the transceiver device and the remote location. A converterunit converts transmission of the data between the implantable medicaldevice, the transceiver device, and the communication device from afirst telemetry format to a second telemetry format, and a directinterface couples the transceiver device to an external device to enabledirect downloading of the data and configuration/setup information tothe external device, and connection to user interface devices. Anexternal reference sensor senses a parameter external to the patient,and the transceiver device receives the sensed parameter from theexternal reference sensor and/or receives data from the implantablemedical device. A user interface enables information to be exchangedbetween the transceiver device and the patient, between the implantablemedical device and the patient through the transceiver device, andbetween the patient and the remote location.

[0011] According to yet another aspect of the present invention, theuser interface includes a patient physiologic parameter portion thatdisplays the physiologic conditions of the patient, a daily activitydiary portion that enables the patient to input activities to thetransceiver device, and a medication reminder portion that displaysmedication reminders in response to a request received from theimplantable medical device and in response to data processed by theimplantable medical device and the transceiver device. An event storageportion stores information, including the input activities and thephysiologic signals associated with the patient, processes theinformation, and acquires high resolution activity in response to theinformation. A send message portion stores messages transmitted betweenthe remote location and the transceiver device and/or the patient, and astatus portion adjusts and displays battery status, therapy status, andsettings of the transceiver device. Finally, a receive message portionof the interface receives messages transmitted between the remotelocation and the transceiver device and/or the patient, includingautomated information, adjusting parameters and output of theimplantable medical device, along with manual information, inputdirectly at the transceiver device.

[0012] According to yet another aspect of the present invention, thedata received by transceiver device is used as feedback controlinformation for a second implantable medical device for implantationwithin the patient.

[0013] According to another aspect of the present invention, a removablememory stores information received directly from the transceiver deviceand received from the implantable medical device through the transceiverdevice.

[0014] According to another aspect of the present invention, thetransceiver device triggers the implantable medical device to changefrom a normal state, in which implantable medical device gathers data ata first rate and performs a relatively high amount of averaging, to asecond state in which the amount and resolution of data is increased sothat an increased resolution of data is obtained and stored intransceiver device in response to an input to the transceiver by thepatient.

BRIEF DESCRIPTION OF THE DRAWINGS

[0015] The features of the present invention which are believed to benovel are set forth with particularity in the appended claims. Theinvention, together with further objects and advantages thereof, maybest be understood by making reference to the following description,taken in conjunction with the accompanying drawings, in the severalfigures of which like reference numerals identify like elements, andwherein:

[0016]FIG. 1 is a schematic view of an implantable medical device systemaccording to the present invention.

[0017]FIG. 2 is a schematic diagram of a transceiver device of theimplantable medical device system of FIG. 1 according to the presentinvention.

[0018]FIG. 3 is a schematic diagram of multi-directional datatransmission using a transceiver device of the implantable medicaldevice system of FIG. 1.

[0019]FIG. 4 is a schematic diagram of a user interface of a transceiverdevice of the implantable medical device system of FIG. 1.

[0020]FIG. 5 is a schematic diagram of remote processing of animplantable medical device according to the present invention.

[0021]FIG. 6 is a schematic diagram of multi-directional datatransmission using a transceiver device of the implantable medicaldevice system of FIG. 1.

[0022]FIG. 7 is a schematic diagram of multi-directional datatransmission using a transceiver device in the implantable medicaldevice system of FIG. 1.

[0023]FIG. 8 is a schematic diagram of multi-directional datatransmission using a transceiver device in the implantable medicaldevice system of FIG. 1.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

[0024]FIG. 1 is a schematic view of an implantable medical device systemaccording to the present invention. As illustrated in FIG. 1, animplantable medical device system 100 according to the present inventionincludes an implantable medical device 102 implanted within a patient104 for delivering a therapy in response to physiological conditions ofpatient 104, or for monitoring conditions of patient 104. Implantablemedical device 102 may be an implantable cardiac pacemaker, such asthose disclosed, for example, in U.S. Pat. No. 5,158,078 to Bennett etal., U.S. Pat. No. 5,312,453 to Shelton et al., or U.S. Pat. No.5,144,949 to Olson, hereby incorporated herein by reference in theirrespective entireties. Implantable medical device 102 may also be apacemaker/cardioverter/defibrillator (PCD), such as those disclosed, forexample, in U.S. Pat. No. 5,545,186 to Olson et al., U.S. Pat. No.5,354,316 to Keimel, U.S. Pat. No. 5,314,430 to Bardy, U.S. Pat. No.5,131,388 to Pless, or U.S. Pat. No. 4,821,723 to Baker et al., allhereby incorporated herein by reference in their respective entireties.

[0025] Alternately, implantable medical device 102 may be an implantablenerve stimulator or muscle stimulator, such as those disclosed in U.S.Pat. No. 5,199,428 to Obel et al., U.S. Pat. No. 5,207,218 to Carpentieret al., or U.S. Pat. No. 5,330,507 to Schwartz, or an implantablemonitoring device, such as the device described in U.S. Pat. No.5,331,966 issued to Bennet et al., all of which are hereby incorporatedherein by reference in their respective entireties. By way of furtherexample, implantable medical device 102 may be an implantable nervestimulator or muscle stimulator, such as those disclosed in U.S. Pat.No. 5,199,428 to Obel et al., U.S. Pat. No. 5,207,218 to Carpentier etal., or U.S. Pat. No. 5,330,507 to Schwartz, or an implantablemonitoring device, such as that disclosed in U.S. Pat. No. 5,331,966issued to Bennet et al., all of which are hereby incorporated herein byreference in their respective entireties. Implantable medical device 102may also be an implantable blood oxygen sensing monitor or animplantable hemodynamic monitor.

[0026] According to the present invention, implantable medical device102 monitors any number, combination or type of parameters, such asoxygen, pressure, cardiac flow, stroke volume, cardiac EGM, cardiacacceleration, etc. While implantable medical device 102 has beendescribed as being one of the above-referenced devices, it is understoodthat the present invention is applicable in any form of implantablemedical device requiring storage of appreciable amounts of physiologic,diagnostic, system, or other data, particularly those that acquireinformation on a continuous or near continuous basis.

[0027] In addition, according to the present invention, a transceiverdevice 106, such as a pager, band-aid, wristwatch, or pendant typedevice, is worn by, attached to, or positioned within close proximity topatient 104 in order to be bi-directionally coupled to implantablemedical device 102 along a wireless telemetry link 108. Telemetry link108 will be dependent upon the type of implantable medical deviceutilized. For example, in a medium range system, telemetry link 108 willtypically range from approximately 0.1 to 1.0 meters.

[0028] Transceiver device 106 is also coupled, along a wireless link110, such as a RF (UHF) link or an infrared (Ir) link, for example, to acommunication device 112, located near or within the patient's home.According to the present invention, communication device 112 includes abase station, a monitor, a physician programmer, or other similar deviceand is connected to the internet 120 through a transmission medium 118,such as a modem, cell phone, or Ethernet, etc. In this way, transceiverdevice 106 exchanges data with a remotely located applications and datastorage unit 114, or a remotely located health care provider 116 throughtransmission medium 118.

[0029] Link 110 will be dependent upon the transmission limitationsdesigned for transceiver device 106 and communication device 112, and ina preferred embodiment of the present invention ranges fromapproximately 1.0 to 100 meters, for example. An additional input orsensor 122 inputs information external to patient 104, such asbarometric pressure, temperature, patient body position, and patientposture, for example, to communication device 112. In this way, byenabling bi-directional transmission of data between implantable medicaldevice 102 and remote locations, such as data storage unit 114 or healthcare provider 116, for example, and between patient 104 and implantablemedical device 102, the present invention enables a more seamless methodfor controlling therapy associated with implantable medical device 102,transmitting data physiologic data remotely back to the physician, inreal time, closing a loop between multiple implantable devices, andproviding additional processing power in order to perform algorithmsexternally from implantable medical device 102, as will be describedbelow.

[0030]FIG. 2 is a schematic diagram of a transceiver device of theimplantable medical device system of FIG. 1 according to the presentinvention. As illustrated in FIG. 2, transceiver device 106 includes amedium range telemetry unit 130 for enabling bi-directional transmissionof data between transceiver device 106 and implantable medical device102. In addition, in situations where a second implantable medicaldevice 132 is located within patient 104, transceiver device 106 of thepresent invention performs bi-directional data transmission with eitherone or both of implantable medical devices 102 and 132. An environmentalsensor unit 134 includes sensors for determining environmentalconditions such as body position of patient 102, temperature, orbarometric pressure. A memory unit 136 is utilized to store code andalgorithms, in addition to data and usage storage log and directories. Atransceiver unit 138 enables the transmission of data betweentransceiver device 106 and communication device 112 for seamlesstransmission to remote locations over the Internet. A removable memory140, such as a PC card, etc., located within transceiver device 106enables information received either directly from transceiver device 106or from implantable medical device 102 through transceiver device 106 tobe stored thereon. Once the information is stored, removable memory 140may then be removed from transceiver device 106 and transferred bypatient 104 to a physician or other medical personnel, such as whenpatient 104 does not have Internet connectivity, for example.

[0031] According to the present invention, patient 102 inputsinformation to transceiver device 106 through buttons, keys, etc.,located at a user interface 142 of transceiver device 106. In addition,user interface 142 includes a display, LEDs and so forth, along with oneor more alarms and speakers, for example, to enable information to betransmitted directly from transceiver device 106 to patient 104, or fromimplantable medical device 102 to patient 104 through transceiver device106, and to enable manual or automated message to be transmitted fromthe remote location 114 and 116 to the patient. A direct interface 144,such as an infrared port, a or serial port, or a universal serial busconnects transceiver device 106 to an external device, such as a laptop,for example, to enable direct downloading of data, configuration/setupinformation, connection to user interface devices, and so forth. A powersource 146, including one or more rechargeable batteries for example,along with recharge circuitry to power transceiver device 106, isincluded within transceiver device 106, along with a clock 148, whichtime stamps all data flowing within transceiver device 106 to correlatewhen certain events are taking place. A GPS unit 150 located withintransceiver device 106 enables the position of transceiver device 106,and therefore the position of patient 104, to be determined whennecessary. Finally, a processor 152 located within transceiver device106 exchanges information with each of devices 130-150, controls therapyassociated with implantable medical device 102, controls transmission ofdata between implantable medical device 102 and a remote location, suchas data storage unit 114 or a health care provider 116, provides realtime data that can be transmitted from patient 104 to the remotelocation, including a physician for example, closes a loop betweenmultiple implantable devices, and provides processing power external toimplantable medical device 102.

[0032]FIG. 3 is a schematic diagram of multi-directional datatransmission using a transceiver device of the implantable medicaldevice system of FIG. 1. As illustrated in FIG. 3, according tomulti-directional data flow transmission of the present invention, animplantable medical device 202, such as the Medtronic Inc. Chronicle IHMwith medium range telemetry, for example, exchanges data with atransceiver device 206 along a link 208 between implantable medicaldevice 202 and a transceiver 238. Transceiver device 206 includes apager type device, for example, positioned within close proximity to, orworn on a belt of the patient, or a band-aid, wristwatch, or pendanttype device positioned within close proximity of the patient. Link 208is a 3 Mhz body wave telemetry link, for example.

[0033] An external reference sensor 214 senses a parameter external tothe patient, such as barometric pressure, for example. It is understoodthat, while sensor 214 is described in FIG. 3 as being a barometricpressure sensor, according to the present invention, sensor 214 couldsense any parameter external to the patient, such as temperature,position of the patients body, patient posture activity, and so forth.Transceiver device 206 exchanges information with a communication device212 along a wireless link 210 between a transceiver 239 of transceiverdevice 206 and a transceiver 217 located within communication device212. Link 210 is, for example, a 433 MHz radio frequency (RF) linkhaving a range of approximately 10 to 30 meters. Communication device212, which according to the present invention includes a base station, amonitor, a programmer or similar device, in turn exchanges informationwith a remote location, such as data storage unit 114 or a health careprovider 116 (FIG. 1) through a modem 218 and the Internet 120.

[0034] A user interface 242 is similar to interface 142 of FIG. 2, andincludes an LCD, audible tones and input buttons to enable the patientto input information within transceiver device 206 at any time, so thatthe present invention provides the patient with an increased level ofcontrol over their health and/or therapy. For example, according to thepresent invention, during an initial visit, a physician may instruct thepatient to ingest a certain drug if the patient's heart rate reaches acertain level or if the patient's blood pressure reaches a certain levelso that once the patient's heart rate or blood pressure is subsequentlydisplayed on LCD of interface 242 as being above the prescribed level,the patient is able to act accordingly on their own.

[0035] In addition, according to the present invention, once the heartrate or blood pressure reaches the prescribed level, an audible alarmsounds from interface 242 to inform the patient of the status of theparameter. Likewise, according to the present invention, information andinstructions can be communicated from the remote location to the patientthrough transceiver device 206 and communication device 212. Forexample, the physician at remote location 116 (FIG. 1) transmitsreminders or requests for the patient to visit the physician, directionsto remote location 116, and so forth, or manual or automated messagesare transmitted from the physician, which are displayed to the patientat user interface 242, or transmitted to the patient using audible tonesof interface 242. Battery levels, drug levels of drug pumps, andinformation regarding other type of therapies that the patient iscurrently on are also displayed at interface 242. In addition,medication reminders, which are displayed or audibly transmitted atinterface 242, are changed or updated at remote location 114 and 116, sothat when, as a result of data remotely received and conversations heldbetween the physician and the patient, a need to change medicationlevels is identified, the physician is able to download the changedirectly within transceiver device 206 and the reminder schedule wouldbe updated.

[0036] In addition, transceiver device 206 of the present inventionenables the patient, during a heart palpitation, for example, or othersuch event, to activate an input at interface 242 to store detailedtherapy status or physiologic signals regarding the event. Once informedof the event, transceiver device 206 triggers implantable device 202 tochange from a normal state, in which implantable medical device 202gathers data at a slow rate, or not at all, and performs a relativelyhigh amount of averaging, to an increased state in which the amount andresolution of data is increased, so that a higher resolution of data canbe obtained and stored in transceiver device 206, concurrent with theonset of the event, which can then be utilized in future diagnosis bythe physician.

[0037] In addition, as illustrated in FIG. 3, microcontroller 252 oftransceiver device 206 receives and correlates raw pressure datareceived from sensor 214 to atmospheric pressure and determines, usingthe correlated data and a predetermined algorithm, whether drug dosagesshould be increased or decreased or whether a closed loop drug or othertherapy (electrical pacing, etc.) should take place. This determinationis then transmitted along link 208 to implantable medical device 202 orto remote location 114 and 116 (FIG. 1), which responds accordingly. Forexample, in a situation where implantable medical device 202 is a drugdelivery device, implantable medical device 202 adjusts dosage amountsaccordingly, or where an implantable medical device 202 is animplantable cardiac pacemaker, implantable medical device 202 increasesthe pacing rate of the patient either automatically, or in response toinput received from a physician located at a remote location, such ashealth care provider 116, through communication device 212 andtransceiver device 206.

[0038]FIG. 4 is a schematic diagram of a user interface of a transceiverdevice of the implantable medical device system of FIG. 1. Asillustrated in FIGS. 3 and 4, interface 242 of the present inventionincludes a patient physiologic parameter portion 260 that displaysphysiologic data of the patient, such the patient's heart rate, bloodpressure, and so forth, and a daily activity diary portion 262 thatenables the patient to enter activities such as eating activity,sleeping activity, exercise activity, restroom visits, and so forth. Amedication reminder portion 264 uses clock 148 (FIG. 2) to displaymedication reminders, or displays reminders in response to a requestreceived by transceiver device 206 from implantable medical device 202,and/or in response to data processed by implantable medical device 202and transceiver device 206. An event storage portion 266 storesphysiologic signals associated with the patient, processes signals,acquires the high resolution signal activity, and so forth, while a sendmessage portion 268 stores messages transmitted between the remotelocation 116 and transceiver device 206 and/or the patient, such as adata snap shot, text messages from the physician, an event trigger, suchas a tachycardia or bradycardia event, and so forth. An implantablemedical device status portion 270 adjusts and/displays battery status,therapy status, and device settings, while a receive message portion 272stores messages transmitted between remote location 114 and transceiverdevice 206 and/or the patient, such as automated information thatadjusts parameters or output of implantable medical device 202, ormanual information input directly at transceiver device 206. Asillustrated in FIGS. 3 and 4, in a low power standby mode 274,transceiver device 206 powers circuits that are not required, such asthose associated with portions 260-272 of interface 242. While instandby mode 274, transceiver device 206 periodically “listens” forsignals from either implantable medical device 202 or communicationdevice 212 to transition from standby mode 274 to an active mode.

[0039]FIG. 5 is a schematic diagram of remote processing of animplantable medical device according to the present invention. Asillustrated in FIGS. 1, 2, 4 and 5, the present invention enablesinformation external to the patient, such as barometric pressure,temperature, patient body position and patient posture to be sensedthrough sensor 122. Transceiver device 106 performs calculations basedon the external information from sensor 122, and/or additionalinformation from implantable medical device 102 stored over a storageinterval, such as diastolic, systolic and other parameters. The resultsof the calculations are then stored in transceiver device 106 ortransmitted to implantable medical device 102 along link 108. As aresult, the present invention enables data from both implantable medicaldevice 102 and transceiver device 106 to be used to trigger highresolution storage or alarms based on hemodynamic parameters.

[0040] According to the present invention, an audible alarm from userinterface 142 alerts patient 104 of hemodynamic parameters that areoutside predetermined limits, and reasons or explanations for the alarmare provided at the display of interface 142, along with suggestions forreturning the parameters back to acceptable levels through drug or dietadjustments, for example. Alternatively, the present invention enablesdata from status portion 270 of transceiver device 106 to be accessed bypatient 104 and described to a physician or caretaker in conversationsduring adverse events. Furthermore, if more than one device is implantedwithin patient 104, such as implantable medical devices 102 and 132,data obtained by transceiver device 106 based on information receivedfrom implantable medical device 102 is used as feedback controlinformation for implantable medical device 132. Implantable medicaldevice 132 includes implanted or external drug pumps, for example, orother such device.

[0041] Transceiver device 106 accesses external information from sensor122 to provide implantable medical device 102 directly with informationfor improved operation and/or additional functions. For example, theaddition of the barometric pressure offset improves internal measuredphysiologic pressure resolution, and enables implantable medical device102 to calculate real diastolic and systolic pressures which could thenbe used to determine pacing and drug therapies, while diagnosticinformation such as external heart rate variability measurements assistin guiding the pacing and drug therapies. In the addition, transceiverdevice accesses external information from sensor 122 for use incalculations relating to operation functions of implantable medicaldevice 102, transmitting the results of the calculation to implantablemedical device 102 or communication device 106, which then respondaccordingly, or displays information or transmits an alarm to patientthrough interface 142.

[0042] Transceiver device 106 of the present invention also enablespatient 104 to input information regarding the status of patient 104that would assist one or both devices 102 and 106. For example, patient106 informs transceiver device 106 when going to sleep, of measured bodyweight, when feeling ill or pre-syncopal, or when a syncopal episode hasjust taken place. Based on this patient input, transceiver device 106either stores the information internally for later diagnostic use withimplantable medical device 102, provides the information directly toimplantable medical device 102 or to communication device 106, orperforms a calculation using the patient input. Upon receipt,implantable medical device 102 then utilizes the patient input toperform calculations, to change a therapy, or to deliver a therapy. Forexample, according to the present invention, implantable medical device102 increases a pacing rate as a result of information input by thepatient at transceiver device 106.

[0043] Alternately, upon receiving information from patient 104 orsensor 122, transceiver device 106 can change monitoring modes. Forexample, transceiver device 106 changes the resolution of storage toenable more data to be recorded, or waits several minutes afterreceiving a message from patient 104 that patient 104 is going to sleepto initiate recording of baseline ECG or other patientparameters/signals. Likewise, a physician is able to remotely access theinformation input at transceiver device 106 by the patient throughcommunication device 106.

[0044] The present invention enables system 100 to be automaticallyreprogrammed at a remote server, such as applications and data storageunit 114 (FIG. 1), or to be manually reprogrammed by patient 104, orremotely reprogrammed at remote location 116, or in a hospital,surgical, intensive care setting, by the physician, such as when thephysician determines that the status of the patient has changed,resulting in a need for implantable medical device 102 to bereprogrammed, or in response to determining that there is a need torestart system 100 after having retrieved frozen or other data.

[0045] In addition, transceiver device 106 is used for communication toa box on a version of the same computer that handles programming via atelephonic link for programming during implant of device 102 and postimplant. Transceiver device 106 enables automatically captured data,such as ECG signal, heart rate, pressure signal, pressure parameters,and/or patient activity to be retrieved from implantable medical device102, increasing available memory space for storing additionalparameters, such as heart rate variability requiring DSP algorithmprocessing, or for more frequent measurements for higher resolution.Transceiver device 106 becomes aware of the need to offload theimplanted memory of stored data either on a periodic polling, or via anautomatic or semi-automatic link, or interactively by patient 104interactive control through interface 142. Transceiver device 106 eitherdirectly transmits the corresponding retrieved data to communicationdevice 112, acts as an intermediate storage medium transmitting theretrieved data to remote locations 114 and 116 for data viewing andanalysis, or performs calculations based on the retrieved data andtransmits the results of the calculations to implantable medical device102, to communication device 112, or to interface 142 for display or fortransmitting an alarm signal to the patient.

[0046] It will be appreciated that the present invention can be utilizedto monitor a patient and/or an implantable medical device implanted in apatient while in a hospital or intensive care setting by enablinginformation from the implantable medical device to be obtainedwirelessly. Furthermore, according to the present invention, uponreceipt of data from implantable medical device 102 and/or externalinformation from sensor 122, and after performing the calculations usingthe received data and/or external information, transceiver device 106either transmits the calculation results to implantable medical device102 and/or communication device 112, transmits instructions associatedwith the calculation results to implantable medical device 102, ortransmits a message or warning to the patient through interface 142. Inresponse to receiving the calculation results or instructions,implantable medical device 102 either performs a therapy or calculation,or stores the calculation results or instruction for future reference.In the alternative, upon receipt, transceiver device 106 merelytransmits the data and/or external information directly to communicationdevice 112.

[0047] According to the present invention, transceiver device 106 warnspatient 104 of device status issues through visual or audible feedbackvia status portion 270 of interface 142, and/or warns the physician orcaretaker via communication device 112 or at the remote location.Important device status issues could include, for example, low batteryand need for replacement, compromise in proper function of implantablemedical device 102 due to system or subsystem failure, excess currentamounts being utilized in a present mode of operation causing device 102to go to low battery prematurely, heart rhythm or cardiac status isindicative of a major problem already ongoing or imminent, and so forth.

[0048] Finally, transceiver device 106 also incorporates other usefulancillary features, such as being a standard time-piece, remindingpatient 104, either visually, audibly or both to take medicines, or ofactivity restrictions related to activities that the physician hasinstructed patient 104 not to engage in.

[0049]FIG. 6 is a schematic diagram of multi-directional datatransmission using a transceiver device of the implantable medicaldevice system of FIG. 1. As illustrated in FIG. 6, according tomulti-directional data flow transmission of the present invention, animplantable medical device 302, such as the Medtronic Inc. Chronicleimplantable hemodynamic monitor (IHM) for cardiac heart failure with amedium range telemetry link, for example, exchanges data with atransceiver device 306 along a link 308 between implantable medicaldevice 302 and a transceiver 338. Transceiver device 306 includes apager type device, for example, positioned within close proximity to, orworn on a belt of the patient, or a band-aid, wristwatch, or pendanttype device positioned within close proximity of the patient, and soforth. Link 308 is a 3 Mhz body wave telemetry link, for example.

[0050] An external reference sensor 314 senses a parameter external tothe patient, such as barometric pressure, and provides the externalparameter to a microcontroller 352 of transceiver device 306 along aserial connection 353. It is understood that, while sensor 314 isdescribed in FIG. 3 as being a barometric pressure sensor, according tothe present invention, sensor 314 could sense any parameter external tothe patient, such as, for example, temperature, position of the patientsbody, patient posture activity, and so forth.

[0051] Transceiver device 306 exchanges information with a communicationdevice 312 along a wireless link 310 between a transceiver 339 oftransceiver device 306 and a transceiver 317 located withincommunication device 312. Wireless link 310 is, for example, a 433 MHzradio frequency (RF) link having a range of approximately 30 to 70meters. Communication device 312, which includes a base station, amonitor, a physician programmer, or other similar device, in turnexchanges information with a remote location, such as data storage unit114 or health care provider 116 (FIG. 1) through a modem type device318. Microcontroller 352 of transceiver device 306 is coupled, whennecessary, such as during setup by a physician or nurse or duringdownload of data, along a serial port 355 to a computer device 357, suchas a laptop computer, palm pilot, or similar device having additionalprocessing power, memory/data storage, and user interface.

[0052] According to the present invention, microprocessor 352 storesdata and performs calculations based on information received fromimplantable medical device 302 or sensor 314, or both. For example,microprocessor 352 receives raw pressure data from sensor 314 andcorrelates atmospheric pressure, for example, to determine, using thecorrelated data and a predetermined algorithm, whether drug dosagesshould be increased or decreased, and transmits the information toimplantable medical device 302, which, in the case where implantablemedical device 302 is a drug delivery device, adjusts dosage amountsaccordingly. In addition, microprocessor 352 transmits data to computerdevice 357 for use during set up, manufacture testing, and design debugprocedures of implantable medical device 302, or for reference by thepatient and/or physician.

[0053] In addition, according to the present invention, new therapyalgorithms, or new enabling therapy features, can be remotely downloadedto the implantable medical device as they become available. Furthermore,the transceiver device can contain algorithms for various purposes, suchas algorithms for altering control of the implantable medical device,for alarms to the patient based on data received from the implantablemedical device, and so forth, which can be downloaded or alteredremotely using the implantable medical device system of the presentinvention.

[0054]FIG. 7 is a schematic diagram of multi-directional datatransmission using a transceiver device in the implantable medicaldevice system of FIG. 1. According to a preferred embodiment of thepresent invention, a transceiver device 406 is coupled to an implantablemedical device 402 along a link 408, such as a short range, low powertelemetry link. Transceiver device 406 includes a band-aid type device,or peripheral memory patch, such as the peripheral memory patch describein U.S. Pat. No. 6,200,265 issued to Walsh et al., and herebyincorporated herein by reference in its entirety. An external referencesensor 414 of transceiver device 406 is coupled along a port 411 toenable sensing of parameters by sensor 414 external to the patient, suchas barometric pressure for example. In addition, external referencesensor 415 is coupled to the skin of the patient through a connector 419to enable transceiver device 406 to sense other external, physiologicalor environmental parameters, such as temperature, physical activity, andso forth. Surface ECG patches 421 are also coupled to the patient's skinthrough a connector 423 to enable transceiver device 406 to collectinformation for forming an electrocardiogram (ECG) of the patient. Skinconnectors 419 and 423 include gel patches, micro needles or any otherdevice for connecting to the patient's skin. Transceiver device 406exchanges information along link 408 with implantable medical device 402through an implantable medical device telemetry unit or transceiver 438and an antenna 441. Information is exchanged between a transceiver 439,such as a UHF transceiver, for example, and a long range source orcommunication device 412, which includes a monitor or physicianprogrammer, for example, along a long range telemetry link 410. Finally,a rechargeable or replaceable battery 446 is positioned provides energyto power transceiver device 406.

[0055] As illustrated in FIG. 7, a microcontroller 452 receives andstores or manipulates information from sensors 414 and 415, patches 421and transceivers 438 and 439, and transmits received, stored, ormanipulated data to implantable medical device 402 and/or long rangesource 412 as described above. For example, transceiver device 406receives a signal from patches 421 and provides ECG signalscorresponding to the patient to long-range source 412 for reference by aphysician or the patient. Barometric data from sensor 414 provides abarometric reference for calibrating an implanted cardiac pressuresensor, which could then be utilized for real-time therapy decisions.

[0056]FIG. 8 is a schematic diagram of multi-directional datatransmission using a transceiver device in the implantable medicaldevice system of FIG. 1. As illustrated in FIG. 8, an implantablemedical device system 500 according to the present invention is similarto those previously described above, and includes an implanted medicaldevice 502 implanted within a patient 504, and a transceiver device 506,such as a pager, band-aid, wristwatch or pendant type device positionedwithin close proximity to implantable medical device 502 to bebi-directionally coupled with implantable medical device 502 along alink 508. In addition, transceiver device 506 is coupled along a link510 to a communication device 512, such as a base station, monitor, orphysician programmer, for example, which in turn is coupled to theinternet 520 and can thus be accessed at a remote location (not shown).Transceiver device 506 utilizes disposable (one-time use), replaceable,or rechargeable batteries (not shown).

[0057] According to a preferred embodiment of the present invention,transceiver device 506 includes a converter unit 501 for convertingbetween various different implantable medical device telemetry formats,each telemetry format having one or more unique features, such ascarrier frequency, modulation method, and/or data protocol. In this way,transceiver device 506 functions as a telemetry repeater of sorts,enabling transmission of data between implantable medical device 502 andtransceiver device 506 in multiple telemetry formats. For example, priorto transmitting the data to communication device 512, converter unit 501converts one of a telemetry range, carrier frequency, modulation method,and/or data protocol associated with information received fromimplantable medical device 502 to a corresponding telemetry range,carrier frequency, modulation method, and/or data protocol associatedwith communication device 512. In the same way, prior to transmittingdata to implantable medical device 502, converter unit 501 converts oneof a telemetry range, carrier frequency, modulation method, and/or dataprotocol associated with information received from communication device502 to a corresponding telemetry range, carrier frequency, modulationmethod, and/or data protocol associated with implantable medical device502. As a result, the present invention eliminates the need fortelemetry cables between communication device 512 and transceiver device506 so that patient 504 is free to go about daily activities while alarge data file is uploaded, or during programming or testing ofimplantable medical device 502. In addition, by eliminating the need fora hard wire connection between transceiver device 506 and communicationdevice 512, the present invention enables transceiver device 506 to moreeasily be entered within a sterile field during an implant procedure,for example, and enables wireless bedside monitoring in a hospital orintensive care setting.

[0058] Converter unit 502 periodically, or at certain physiological orother events, gathers data from implantable medical device 502 andtransmits the gathered data or commands to second implantable medicaldevice 132 (FIG. 2). Transceiver device 506 also includes a memory 503for storing information regarding implantable medical device 502, orconditions of patient 504 over time, so that patient 504 would activatetransceiver device 506 prior to a follow-up visit and interrogate datato be turned into the physician or health care provider. For example,transceiver device 506 would be turned over to the health care providerand read into the physician's programmer, via a PCMCIA or serialinterface, or could also reach the physician via a remote internetconnection. For surgical procedures, a short range implantable medicaldevice telemetry is converted by converter unit 501 to a longer rangeimplantable medical device telemetry, such as a UHF link, for example,enabling the physician programmer to be kept outside the sterile field.In this way, converter unit 501 allows a physician programmer tocommunicate with implantable medical devices 506 and 132, for example,by enabling a physician programmer related to one implantable medicaldevice to communicate with a second implantable medical device differentfrom the first device, removing the cost and complexity from a specificprogrammer or having to utilize separate programmers, while providingthe physician the ability to communicate with multiple implantablemedical devices (telemetry types) in an emergency room setting or in arural clinic, and to store information from a broad range of devices.

[0059] It is understood that while the communication device of thepresent invention has been described above as being base station, amonitor, a physician programmer, or other similar device, communicationdevice also includes an internet device, with or without user controls,that transmits data remotely, such as to a physician programmer at aremote location, or to an internet web page.

[0060] The preceding specific embodiments are illustrative of thepractice of the invention. It is to be understood, therefore, that otherexpedients known to those of skill in the art or disclosed herein may beemployed. In the following claims, means-plus-function clauses areintended to cover the structures described herein as performing therecited function and not only structural equivalents but also equivalentstructures. For example, although a nail and a screw may not bestructural equivalents in that a nail employs a cylindrical surface tosecure wooden parts together, whereas a screw employs a helical surface,in the environment of fastening wooden parts, a nail and a screw areequivalent structures. It is therefore to be understood, that within thescope of the appended claims, the invention may be practiced otherwisethan as specifically described without actually departing from thespirit and scope of the present invention.

What is claimed is:
 1. An implantable medical device system, comprising:an implantable medical device for implantation within a patient, theimplantable medical device monitoring physiologic conditions of thepatient, and/or delivering a therapy in response to the physiologicconditions; a transceiver device, coupled to the implantable medicaldevice along a wireless link, exchanging data with the patient, betweenthe patient and the implantable medical device, and between a remotelocation and the implantable medical device; and a communication device,coupled to the transceiver device along a wireless link, exchanging datawith the transceiver device, with the implantable medical device throughthe transceiver device, and between the transceiver device and theremote location, wherein the implantable medical device system enablesbi-directional data transfer between the patient, the implantablemedical device, the transceiver device, the communication device, andthe remote location.
 2. The implantable medical device system of claim1, the system further comprising a converter unit convertingtransmission of the data between the implantable medical device, thetransceiver device, and the communication device from a first telemetryformat to a second telemetry format.
 3. The implantable medical devicesystem of claim 1, further comprising a direct interface coupling thetransceiver device to an external device to enable direct downloading ofthe data and configuration/setup information to the external device, andconnection to user interface devices.
 4. The implantable medical devicesystem of claim 1, wherein the transceiver device includes one of apager type device, a band-aid, a wristwatch, and a pendant type device.5. The implantable medical device system of claim 1, further comprisingan external reference sensor sensing a parameter external to thepatient, the transceiver device receiving the sensed parameter from theexternal reference sensor and/or receiving data from the implantablemedical device, wherein the transceiver device either directly transmitsthe sensed parameter and/or the data received from the implantablemedical device to the communication device, stores the sensed parameterand/or the data received from the implantable medical device forsubsequent transmission to the remote location, performs calculationsbased on the sensed parameter and/or the data received from theimplantable medical device and transmits results of the calculations tothe implantable medical device or the communication device, or transmitsa display or an alarm signal corresponding to results of thecalculation.
 6. The implantable medical device system of claim 1,further comprising a user interface enabling information to be exchangedbetween the transceiver device and the patient, between the implantablemedical device and the patient through the transceiver device, andbetween the patient and the remote location.
 7. The implantable medicaldevice system of claim 6, wherein the user interface comprises: apatient physiologic parameter portion displaying the physiologicconditions of the patient; a daily activity diary portion enabling thepatient to input activities to the transceiver device; a medicationreminder portion displaying medication reminders in response to arequest received from the implantable medical device and in response todata processed by the implantable medical device and the transceiverdevice; an event storage portion storing information, including theinput activities and physiologic signals associated with the patient,processing the information, and acquiring high resolution activity inresponse to the information; a send message portion storing messagestransmitted between the remote location and the transceiver deviceand/or the patient; a status portion adjusting and displaying batterystatus, therapy status, and settings of the transceiver device; and areceive message portion receiving messages transmitted between theremote location and the transceiver device and/or the patient, thereceived messages including one of automated information, adjustingparameters and output of the implantable medical device, and manualinformation, input directly at the transceiver device.
 8. Theimplantable medical device system of claim 1, wherein data received bytransceiver device is used as feedback control information for a secondimplantable medical device for implantation within the patient.
 9. Theimplantable medical device system of claim 1, further comprising aremovable memory storing information received directly from thetransceiver device and received from the implantable medical devicethrough the transceiver device.
 10. The implantable medical devicesystem of claim 1, wherein the transceiver device triggers theimplantable medical device to change from a normal state, in whichimplantable medical device gathers data at a first rate and performs arelatively high amount of averaging, to a second state in which theamount and resolution of data is increased so that an increasedresolution of data is obtained and stored in transceiver device inresponse to an input to the transceiver by the patient.
 11. Theimplantable medical device system of claim 1, wherein the communicationdevice is one of a base station, a monitor, a physician programmer, andan internet device.
 12. The implantable medical device system of claim1, wherein the system transmits a warning in response to status issuescorresponding to the implantable medical device through one of thetransceiver device, the communication device, and the remote location.13. The implantable medical device system of claim 1, wherein thetransceiver device reminds the patient to take medications, and/orreminds the patient of activity restrictions.
 14. The implantablemedical device system of claim 1, wherein the implantable medical devicesystem is reprogrammed directly by the patient or remotely at one of theremote location and the communication device.
 15. A patient wearabletransceiver device exchanging data with an implantable medical devicefor implantation within a patient and a communication device,comprising: means for receiving information from the implantable medicaldevice; means for exchanging data between the patient, the implantablemedical device, the communication device, and a remote location; andmeans for processing the data exchanged to enable bi-directional datatransfer between the patient, the implantable medical device, thetransceiver device, and the remote location.
 16. The device of claim 15,further comprising means for converting data exchanged between theimplantable medical device, the transceiver device, and thecommunication device from a first telemetry format to a second telemetryformat.
 17. The device of claim 15, further comprising direct interfacemeans coupling the transceiver device to an external device to enabledirect downloading of the data and configuration/setup information tothe external device, and connection to user interface devices.
 18. Thedevice of claim 15, wherein the transceiver device includes one of apager type device, a band-aid, a wristwatch, and a pendant type device.19. The device of claim 15, further comprising a sensing means forsensing a parameter external to the patient, the transceiver devicereceiving the sensed parameter from the sensing means and/or receivingdata from the implantable medical device, wherein the transceiver deviceeither directly transmits the sensed parameter and/or the data receivedfrom the implantable medical device to the communication device, storesthe sensed parameter and/or the data received from the implantablemedical device for subsequent transmission to the remote location,performs calculations based on the sensed parameter and/or the datareceived from the implantable medical device and transmits results ofthe calculations to the implantable medical device or the communicationdevice, or transmits a display or an alarm signal corresponding toresults of the calculation.
 20. The device of claim 15, furthercomprising a user interface means for enabling information to beexchanged between the transceiver device and the patient, between theimplantable medical device and the patient through the transceiverdevice, and between the patient and the remote location.
 21. The deviceof claim 20, wherein the user interface means comprises: means fordisplaying the physiologic conditions of the patient; means for enablingthe patient to input activities to the transceiver device; means fordisplaying medication reminders in response to a request received fromthe implantable medical device and in response to data processed by theimplantable medical device and the transceiver device; means for storinginformation, including the input activities and physiologic signalsassociated with the patient, processing the information, and acquiringhigh resolution activity in response to the information; means forstoring messages transmitted between the remote location and thetransceiver device and/or the patient; means for adjusting anddisplaying battery status, therapy status, and settings of thetransceiver device; and means for receiving messages transmitted betweenthe remote location and the transceiver device and/or the patient, thereceived messages including one of automated information, adjustingparameters and output of the implantable medical device, and manualinformation, input directly at the transceiver device.
 22. The device ofclaim 15, wherein data received by transceiver device is used asfeedback control information for a second implantable medical device forimplantation within the patient.
 23. The device of claim 15, furthercomprising means for storing information received directly from thetransceiver device and received from the implantable medical devicethrough the transceiver device, the means for storing information beingremovable from the device.
 24. The device of claim 15, wherein thetransceiver device triggers the implantable medical device to changefrom a normal state, in which implantable medical device gathers data ata first rate and performs a relatively high amount of averaging, to asecond state in which the amount and resolution of data is increased sothat an increased resolution of data is obtained and stored intransceiver device in response to an input to the transceiver by thepatient.
 25. The device of claim 15, further comprising means fortransmitting a warning in response to status issues corresponding to theimplantable medical device through one of the transceiver device, thecommunication device, and the remote location.
 26. The device of claim15, further comprising means for reminding the patient to takemedications and/or of activity restrictions.
 27. An implantable medicaldevice system, comprising: an implantable medical device forimplantation within a patient, the implantable medical device monitoringphysiologic conditions of the patient, and/or delivering a therapy inresponse to physiologic conditions; a transceiver device, coupled to theimplantable medical device along a wireless link, exchanging data withthe patient, between the patient and the implantable medical device, andbetween a remote location and the implantable medical device; acommunication device, coupled to the transceiver device along a wirelesslink, exchanging data with the transceiver device and with theimplantable medical device through the transceiver device, andexchanging data between the transceiver device and the remote location;a converter unit converting transmission of the data between theimplantable medical device, the transceiver device, and thecommunication device from a first telemetry format to a second telemetryformat; a direct interface coupling the transceiver device to anexternal device to enable direct downloading of the data andconfiguration/setup information to the external device, and connectionto user interface devices; an external reference sensor sensing aparameter external to the patient, the transceiver device receiving thesensed parameter from the external reference sensor and/or receivingdata from the implantable medical device; and a user interface enablinginformation to be exchanged between the transceiver device and thepatient, between the implantable medical device and the patient throughthe transceiver device, and between the patient and the remote location.28. The implantable medical device system of claim 27, wherein thetransceiver device either directly transmits the sensed parameter and/orthe data received from the implantable medical device to thecommunication device, stores the sensed parameter and/or the datareceived from the implantable medical device for subsequent transmissionto the remote location, performs calculations based on the sensedparameter and/or the data received from the implantable medical deviceand transmits results of the calculations to the implantable medicaldevice or the communication device, or transmits a display or an alarmsignal corresponding to results of the calculation.
 29. The implantablemedical device system of claim 28, wherein the transceiver deviceincludes one of a pager type device, a band-aid, a wristwatch, and apendant type device.
 30. The implantable medical device system of claim29, wherein the user interface comprises: a patient physiologicparameter portion displaying the physiologic conditions of the patient;a daily activity diary portion enabling the patient to input activitiesto the transceiver device; a medication reminder portion displayingmedication reminders in response to a request received from theimplantable medical device and in response to data processed by theimplantable medical device and the transceiver device; an event storageportion storing information, including the input activities andphysiologic signals associated with the patient, processing theinformation, and acquiring high resolution activity in response to theinformation; a send message portion storing messages transmitted betweenthe remote location and the transceiver device and/or the patient; astatus portion adjusting and displaying battery status, therapy status,and settings of the transceiver device; and a receive message portionreceiving messages transmitted between the remote location and thetransceiver device and/or the patient, the received messages includingone of automated information, adjusting parameters and output of theimplantable medical device, and manual information, input directly atthe transceiver device.
 31. The implantable medical device system ofclaim 30, wherein data received by transceiver device is used asfeedback control information for a second implantable medical device forimplantation within the patient.
 32. The implantable medical devicesystem of claim 31, further comprising a removable memory storinginformation received directly from the transceiver device and receivedfrom the implantable medical device through the transceiver device. 33.The implantable medical device system of claim 32, wherein thetransceiver device triggers the implantable medical device to changefrom a normal state, in which implantable medical device gathers data ata first rate and performs a relatively high amount of averaging, to asecond state in which the amount and resolution of data is increased sothat an increased resolution of data is obtained and stored intransceiver device in response to an input to the transceiver by thepatient.
 34. The implantable medical device system of claim 33, whereinthe communication device is one of a base station, a monitor, aphysician programmer, and an internet device.
 35. The implantablemedical device system of claim 34, wherein the system transmits awarning in response to status issues corresponding to the implantablemedical device through one of the transceiver device, the communicationdevice, and the remote location.
 36. The implantable medical devicesystem of claim 35, wherein the transceiver device reminds the patientto take medications, and/or reminds the patient of activityrestrictions.
 37. The implantable medical device system of claim 36,wherein the implantable medical device system is reprogrammed directlyby the patient or remotely at one of the remote location and thecommunication device.
 38. The implantable medical device system of claim27, wherein the user interface enable information to be exchangedbetween the patient and the communication device.